Breast CancerPhase 1NCT06430541
Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence
A Phase 1 study testing Psilocybin in people with Breast Cancer and Ovarian Cancer, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Ovarian Cancer
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2024to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1, Aged ≥ 21 2. Diagnosis of:
- early-stage breast cancer at low risk of recurrence
- defined as clinical stage 1 or 2
- completed primary treatment (surgery, chemotherapy [adjuvant, patients may continue to be treated with neoadjuvant], and/or radiation) > 6 months ago
- oncologist reported risk of recurrence at 10 years < 20%
- late-stage ovarian cancer at high risk of recurrence
Show all 13Show fewer
- defined as Clinical stage 3 or 4
- currently in remission
- oncologist reported risk of recurrence at 10 years > 80% 2. Functional Status defined as:
- Eastern Cooperative Oncology Group (ECOG) ≤1
- Palliative Performance Scale (PPS) ≥60%
- Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. Have an identified support person
- Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing 6. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.
Who cannot join
- Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:
- Congestive heart failure
- Valvular heart disease
- Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant EKG abnormality (i.e., QTC interval > 450)
- Recent acute myocardial infarction or evidence of ischemia
- Malignant hypertension
Show all 70Show fewer
- Congenital long QT syndrome
- Acute renal failure
- Severe hepatic impairment
- Respiratory failure
- eGFR < 50 mL/min/1.73m2
- LFTs > 1.5 x ULN
- WBC < 5 x 10*9/L
- Hemoglobin < 8.0 g/dL
- Platelets < 150 x 10*9/L
- Risk for hypertensive crisis defined as:
- Screening and Baseline blood pressure >140/90 mmHg
- Significant central nervous system (CNS) pathology
- Examples include:
- Primary or secondary cerebral neoplasm
- Epilepsy
- History of stroke
- Cerebral aneurysm
- Dementia
- Delirium
- Primary psychotic or affective psychotic disorders Examples include current or past DSM-5 criteria for:
- Schizophrenia spectrum disorders
- Schizoaffective disorder
- Bipolar I or bipolar II disorder
- Major Depressive Disorder with psychotic features
- Prior history of psychosis due to medical condition or substance use
- Family history of psychotic or serious bipolar spectrum illnesses.
- Examples include first-degree relative with:
- Schizophrenia spectrum disorders
- Schizoaffective disorder
- Bipolar I disorder with psychotic features
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation and judgement. Examples include:
- Agitation
- Violent behavior
- Active substance use disorders (SUDs) defined as:
- DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year
- DAST-10 score of 3 or higher
- Two or more "yes" responses to CAGE screening questionnaire
- Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as:
- Any use in the last 12 months
- >25 lifetime uses
- Clinically significant suicidality or high risk of completed suicide defined as:
- 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline
- Any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts
- Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior
- History of hallucinogen persisting perception disorder (HPPD)
- Pregnancy/lactation
- Cognitive impairment as defined by:
- Montreal Cognitive Assessment Test (MoCA) < 23
- Concurrent Medications
- Antidepressants
- Centrally-acting serotonergic agents (e.g., MAO inhibitors)
- Serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort)
- Antipsychotics (e.g., first and second generation)
- Mood stabilizers (e.g., lithium, valproic acid)
- Aldehyde dehydrogenase inhibitors (e.g., disulfiram)
- Significant inhibitors of UGT 1A0 or UGT
- 1A10
- Efavirenz
- Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone) unless prescribed, and Phencyclidine (PCP).
- Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin
- Have any psychological or physical symptom, medication, or other relevant finding , based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.
- Have an allergy or intolerance to any of the materials contained in the drug product
- Non-English speaking individual
- Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Outpatient CTRC
Aurora, Colorado, 80045
Stacy Fischer, MD
- Recruiting
University of Colorado Cancer Center
Aurora, Colorado, 80045
Stacy Fischer, MD, 303-724-2406, stacy.fischer@cuanschutz.edu
Stacy Fischer, MD
About this study
Official title: Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission
The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question[s] it aims to answer [is/are]:
Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life?
Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.
- Conditions
- Breast Cancer, Ovarian Cancer
- Being tested
- Psilocybin
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
A tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin Assisted Psychotherapy | Experimental | 25mg cGMP Psilocybin in combination with manualized therapy Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fear of Cancer Recurrence Inventory
Measured by change in core on the Fear of Recurrence Inventory completed at screening and baseline.
The FCRI's total score ranges from 0 to 36, with higher scores indicating greater FCR severity.
Measured: 1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks.
Secondary outcomes (1)
Safety as measured by adverse events
Assess Adverse Events, Treatment Emergent Adverse Events, Serious Adverse Events
Measured: for the duration of study participation -6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start21 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Usona Institute
- Responsible party
- Sponsor
- Investigators
- Stacy Fischer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430541
- Sponsor's protocol ID
- 23-1455.cc
- Other IDs
- NCI-2024-04762
- Status last verified
- Sep 2026
- First submitted
- 21 May 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission
- ClinicalTrials.gov ID
- NCT06430541
- Acronym / sponsor ID
- 23-1455.cc
- Conditions
- Breast Cancer, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Usona Institute
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question[s] it aims to answer [is/are]:
Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life?
Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Assisted Psychotherapy | Experimental | Drug: Psilocybin25mg cGMP Psilocybin in combination with manualized therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- early-stage breast cancer at low risk of recurrence
- late-stage ovarian cancer at high risk of recurrence
- Eastern Cooperative Oncology Group (ECOG) ≤1
- Palliative Performance Scale (PPS) ≥60%
- Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. Have an identified support person
Key exclusion criteria (70 listed)
- Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or EKG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:
- Risk for hypertensive crisis defined as:
- Screening and Baseline blood pressure >140/90 mmHg
- Significant central nervous system (CNS) pathology
- Primary psychotic or affective psychotic disorders Examples include current or past DSM-5 criteria for:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinA tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors. | Drug | Psilocybin Assisted Psychotherapy |
Primary outcome
Change in Fear of Cancer Recurrence Inventory
Time frame: 1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks.
Measured by change in core on the Fear of Recurrence Inventory completed at screening and baseline. The FCRI's total score ranges from 0 to 36, with higher scores indicating greater FCR severity.
1 secondary outcome
Safety as measured by adverse events
Time frame: for the duration of study participation -6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stacy Fischer, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with Breast Cancer and Ovarian Cancer, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 70 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Mancuso (303-724-5729, mary.mancuso@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fear of Cancer Recurrence Inventory (time frame: 1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.